[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Page 20960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Implementation of Post-Approval Studies for Medical Devices; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Implementation of Post-Approval Studies for Medical 
Devices.'' The purpose of the workshop is to facilitate discussion 
among FDA and other interested parties on issues related to the 
implementation of Post-Approval Studies for medical devices.
    Date and Time: The workshop will be held on June 4, 2009, from 9 
a.m. to 5 p.m. and June 5, 2009, from 9 a.m. to 12 p.m. Participants 
are encouraged to arrive early to ensure time for parking and security 
screening before the meeting. Security screening will begin at 8 a.m., 
and registration will begin at 8:30 a.m. Please pre-register by May 28, 
2009, using the instructions in this document.
    Location: The workshop will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Silver Spring, MD 20993.
    Contact Persons: Ellen Pinnow, Center for Devices and Radiological 
Health (HFZ-541), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 240-276-2373, e-mail: [email protected]; or 
Daniel Canos, Center for Devices and Radiological Health (HFZ-450), 
Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 
240-276-2369, [email protected].
    Registration: E-mail your name, title, organization affiliation, 
address, and e-mail contact information to Stephanie Zafonte at 
3.com">SZafonte@s-3.com. There is no fee to attend the workshop, but attendees 
must register in advance. The registration process will be handled by 
Social and Scientific Systems, which has extensive experience in 
planning, executing, and organizing educational meetings. Although the 
facility is spacious, registration will be on a first-come, first-
served basis. Non-U.S. citizens are subject to additional security 
screening, and they should register as soon as possible.
    If you need special accommodations because of a disability, please 
contact Ellen Pinnow (see Contact Persons) at least 7 days before the 
public workshop.

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

    The purpose of the public workshop is to facilitate discussion 
among FDA and other interested parties on issues related to the conduct 
of Post-Approval Studies for medical devices.

II. What Are the Topics We Intend To Address at the Public Workshop?

    We hope to discuss a large number of issues at the workshop, 
including, but not limited to:
     Regulatory requirements for implementing a Post-Approval 
Study for medical devices;
     Challenges and successful strategies for the recruitment 
of participants for Post-Approval Studies;
     Challenges and successful strategies for the retention and 
compliance with follow-up requirements of participants for Post-
Approval Studies;
     Using existing infrastructure (e.g., national registries) 
to facilitate Post-Approval Studies; Using innovative strategies to 
facilitate Post-Approval Studies;
     Clinical research organizations, industry, academia, and 
other clinical trial consultant's perspectives on all of the previous 
issues related to implementing Post-Approval Studies for medical 
devices.

III. Where Can I Find Out More About This Public Workshop?

    Background information on the public workshop, registration 
information, the agenda, information about lodging, and other relevant 
information will be posted, as it becomes available, on the Internet at 
http://www.fda.gov/cdrh/meetings.html.

    Dated: April 29, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-10426 Filed 5-5-09; 8:45 am]
BILLING CODE 4160-01-S